HHS Announces Covid-19 Public Health Emergency Transition Plans The US Department of Health and Human Services (HHS) has announced policy changes now that the Public Health Emergency (PHE) phase for COVID-19 has expired. While the spread of SARS-CoV-2, the virus that causes COVID-19, remains a public health priority, the HHS said we are better prepared in our response to viral outbreaks than we were three years ago and can now transition away from the emergency phase. The HHS will focus on improving standards of care in partnership with state, local, tribal, and territorial agencies, industry, and advocates, to ensure an orderly transition. Over the last two years, the Biden Administration has implemented the largest adult vaccination program in US history, with nearly 270 million Americans receiving at
least one shot of a Covid-19 vaccine. Since the peak of the Omicron surge at the end of January 2022, daily Covid-19 cases are down by 92 per- cent, deaths have declined by over 80 percent, and new Covid-19 hospitalizations are down nearly 80 percent. Covid-19 vaccines and treatments, such as Paxlovid and Lagevrio, will continue to be accessible to all who need them. When the transition to traditional health care cover- age occurs later this year, many Americans will continue to pay nothing out-of-pocket for the COVID-19 vaccine. Vaccines are a preventive health service for most private insurance plans and will be fully covered without a co-pay. Covid-19 products, including tests, vaccines, and treat- ments, will also not be affected. Here's a glance at what will be affected: • Certain Medicare and Medicaid waivers and broad flexibilities for health care providers. The waivers were necessary to expand healthcare facility capacity during the pandemic. • Access to free over-the-counter COVID-19 testing will end unless insurance companies continue to include it. • Reporting of COVID-19 laboratory results
DESIGNS THAT INCREASE PRODUCTION
and immunization data to CDC is no longer authorized, but the CDC has been working on voluntary Data Use Agreements, encouraging states and jurisdictions to continue sharing vaccine administration data. Hospital data re- porting will continue to be required. • Certain FDA COVID-19-related guidance documents for industry that affect clinical practice and supply chains will end or be tem- porarily extended. • Food & Drug Administration’s (FDA) abili- ty to detect early shortages of critical devices related to COVID-19 diagnosis and treatment will be more limited. While the FDA will main- tain its authority to detect other potential med- ical product shortages, it is seeking congres- sional authorization to extend the requirement for device manufacturers to notify FDA of significant interruptions and discontinuances of critical devices outside of a Public Health Emergency (PHE). • Public Readiness and Emergency Pre- paredness (PREP) Act liability protections may be impacted. The amended PREP Act that provides liability immunity to manufacturers, distributors will not be affected, but liability protections for countermeasure activities not related to any USG agreement will end. • The ability of health care providers to safely dispense controlled substances via telemedicine without in-person interaction is affected; however, rulemaking will be pro- posed to extend these flexibilities. To see the full report, visit hhs.gov .
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May 22, 2023
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